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Certificado nº 60125635

  • Número de Certificado
    HD 60125635
  • Certificado Titular
    "Astar ABR"
    Aleksander Jedrzejowski,
    Robert Dziendziel Spolka Jawna
    ul. Swit 33
    43-382 Bielsko-Biala
    Polonia
  • Alcance de la Certificación

    (see attachment for products included)
    Replaces Certificate, Registration No.: HD 60097823 0001
    Products included:
    - Electrotherapy devices
    - Light therapy devices
    - Laser therapy devices
    - Magnetic field therapy devices
    - Ultrasound therapy devices
    - Ultrasound therapy combined with electrotherapy devices
    - Vacuum therapy devices
    - Shock wave physical therapy devices

  • Estándares cumplidos
    Richtlinie 93/42/EWG
  • Tipo de Certificado
    Vollst. QMS, Anhang II MDD

    EC declaration of conformity (Full quality assurance system)
    Certificate according to Annex II Section 3 of the EC Directive 93/42/EEC concerning Medical Devices

    The Notified Body hereby certifies the application of the quality system by the manufacturer approved for the design, manufacture and final inspection of the products concerned, as specified in Annex II, Section 3 of the EC directive 93/42/EEC.

    The manufacturer is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5.

    This approval can be used by the company in line with the declaration of conformity.